Therapeutic Goods Amendment Regulations 2009 (No. 4) (Cth)

Therapeutic Goods Amendment Regulations 2009 (No. 4)¹

Select Legislative Instrument 2009 No. 179

I, QUENTIN BRYCE, Governor-General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the Therapeutic Goods Act 1989.

Dated 9 July 2009

QUENTIN BRYCE

Governor-General

By Her Excellency’s Command

MARK BUTLER

Parliamentary Secretary for Health

Name of Regulations

These Regulations are the Therapeutic Goods Amendment Regulations 2009 (No. 4).

Commencement

These Regulations commence on 10 July 2009.

Amendment of Therapeutic Goods Regulations 1990

Schedule 1 amends the Therapeutic Goods Regulations 1990.

Schedule 1 Amendments

(regulation 3)

[1] Regulation 45A, heading

substitute

45ACharges reduced if annual turnover is not more than $76 800

[2] Schedule 9, Part 2, items 1A, 1, 2, 2AA, 2A, 2B, 2C, 3 and 3AA

substitute

1A	Application fee for processing an application for consent under section 14 of the Act	370
1	Evaluation fee for the purposes of subparagraph 19 (2) (b) (iii) of the Act: (a) if: (i) the goods are medicines for use solely for experimental purposes in humans; and (ii) the evaluation consists of the consideration of: (A) a summary of chemical, pharmaceutical and biological information about the goods; and	1 360
(B) descriptive information about the proposed clinical trial of the goods; and (C) information about adverse events associated with the use of the goods; and (D) information about the goods provided to the relevant ethics committee; — for each medicine
(b) if the goods are medicines for use solely for experimental purposes in humans (other than medicines to which paragraph (a) applies) — for each medicine	16 900
(c) if the goods are therapeutic devices referred to in item 3 of Part 1 of Schedule 3 for use solely for experimental purposes in humans where clinical studies are conducted to demonstrate safety and effectiveness	14 300
(d) if the goods are therapeutic devices for use solely for experimental purposes in humans and are goods to which paragraph (c) does not apply	2 150
2	Application fee for the purposes of paragraph 23 (2) (a) of the Act for registration of therapeutic goods (if regulation 43A does not apply and the application is not an application to which item 2AA or 3A applies):
(a) for an application relating to a medicine to which item 4 does not apply	1 230
(b) for an application relating to a therapeutic device of a kind mentioned in Part 2 of Schedule 3	1 140
(ba) for an application relating to a medicine to which item 4 applies, if: (i) the Secretary considers that the application cannot be determined because of insufficiency of information delivered (Act, paragraph 23 (2) (b)); or (ii) the application is withdrawn before notification of acceptance is sent under subregulation 16B (1)	7 600; or 20% of the relevant fee under item 4; whichever is the less
(c) subject to paragraph (d), for an application in any other case (d) subject to paragraph (f), if a person submits more than one application at the same time and: (i) the additional application is in relation to goods that contain the same therapeutically active ingredient or are therapeutic devices; and (ii) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous evaluation of the goods to be made	3 420 1 710 — for each additional application, up to a maximum amount payable of $9 960 (including the fee payable under paragraph (c))
(f) if a person submits at the same time more than one application relating to item 5 and: (i) each of which relates to goods that contain the same therapeutically active ingredient; and (ii) the information in support of each of which is sufficiently common in respect of the goods to enable a simultaneous evaluation of the goods to be made; for each additional application	540
(g) if: (i) a person submits at the same time more than 1 application relating to item 7; and (ii) the information in support of the applications is sufficiently common in respect of the therapeutic devices to which they relate to enable simultaneous evaluation of the devices; for each additional application	1 140
(h) if: (i) a person submits at the same time more than 1 application for a therapeutic device of a kind mentioned in Part 2 of Schedule 3; and (ii) the information in support of the application for each device is sufficiently common to enable simultaneous evaluation of each of the devices; for each additional application	580
2AA	Application fee for the purposes of paragraph 23 (2) (a) of the Act for the registration of therapeutic goods if the previous registration was cancelled solely because of failure to pay the annual registration charge and the application is made within 30 days of the cancellation	520
2A	Fee for varying an entry in the Register (not including evaluation of data) under subsection 9D (1), (2) or (3) of the Act, if the variation is for:
(a) a registered medicine that is mentioned in Part 1 of Schedule 10 — for each submission	1 320
(b) a registered medicine that is mentioned in Part 2 or Part 3 of Schedule 10	1 230
(c) a listed medicine	320
(d) a registered therapeutic device that is mentioned in Part 2 of Schedule 3	350
(e) a registered therapeutic device, other than a device mentioned in paragraph (d)	350
(f) a listed therapeutic device	350
(g) a medical device	350
2B	Fee for an application to which regulation 16F or 16G applies, for evaluation of the chemistry, quality control or manufacturing process of the medicine — for each submission	4 290
2C	Fee for an application under subsection 9D (1), (2) or (3) of the Act (other than an application to which item 4 applies), for evaluation of clinical, pre‑clinical or bioequivalence data, or the chemistry, quality control or manufacturing process, of the goods	4 290
3	Application fee for paragraph 23 (2) (a) of the Act for the listing of therapeutic goods (other than for an application to which regulation 43A, or item 3AA applies) if the goods are:
(a) a device	350
(b) a medicine	640
3AA	Application fee for the purposes of paragraph 23 (2) (a) of the Act for the listing of therapeutic goods if the previous listing was cancelled solely because of failure to pay the annual listing charge and the application is made within 30 days of the cancellation	520

[3] Schedule 9, Part 2, items 4, 5, 5A, 5B, 6, 6AA, 6AB, 6ABA, 6AC, 6AD, 6A, 6B, 6C, 6D and 7

substitute

4	Evaluation fee, for subsection 24 (1) of the Act, under a submission (if paragraph (ba) of item 2 does not apply) for evaluation relating to:
(a) a new chemical entity (other than an entity to which paragraph (aa) applies)	187 900
(aa) a new chemical entity incorporated as an ancillary medicinal component of a medical device or a therapeutic device if the evaluation of the new chemical entity involves an evaluation of:
(i) documentation setting out the chemistry, quality control and manufacturing of the new chemical entity; or	one‑third of the fee specified in paragraph (a)
(ii) documentation relating to pre‑clinical studies; or	one‑third of the fee specified in paragraph (a)
(iii) documentation mentioned in subparagraphs (i) and (ii)	two‑thirds of the fee specified in paragraph (a)
(b) an extension of indications (other than an extension of indications to which paragraph (bb) applies) (bb) an extension of indications or a major variation in respect of a medicine incorporated as an ancillary medicinal component of a medical device or a therapeutic device if the evaluation of the medicine involves an evaluation of:	111 700
(i) documentation setting out the chemistry, quality control and manufacturing of the medicine; or	one‑third of the fee specified in paragraph (b) or (g) for an evaluation of that nature
(ii) documentation relating to pre‑clinical studies; or	one‑third of the fee specified in paragraph (b) or (g) for an evaluation of that nature
(iii) documentation mentioned in subparagraphs (i) and (ii)	two‑thirds of the fee specified in paragraph (b) or (g) for an evaluation of that nature
(c) a new generic product	71 700
(d) an additional trade name	11 800
(e) a change to product information	4 290
(f) a change to consumer patient information	1 320
(g) a major variation (that is not a variation mentioned in any of paragraphs (a) to (f))	72 800
(h) a minor variation (that is not a variation mentioned in any of paragraphs (a) to (f))	4 290
5	Evaluation fee: (a) under subsection 24 (1) of the Act — in respect of a medicine to which item 4 does not apply, if the evaluation documentation does not contain clinical or toxicological information (b) under subsection 24 (1) of the Act — in respect of a medicine to which item 4 does not apply, if the evaluation documentation contains clinical or toxicological information, and the total number of pages is:	8 190
(i) not over 50 pages	8 190
(ii) over 50 pages, but not over 250 pages	10 500
(iii) over 250 pages, but not over 500 pages	14 400
(iv) over 500 pages, but not over 1 000 pages	19 100
(v) over 1 000 pages, but not over 2 000 pages	28 700
(vi) over 2 000 pages, but not over 3 000 pages	38 300
(vii) over 3 000 pages	57 300
(c) under subsection 9D (1), (2) or (3) of the Act ¾ in relation to an entry in the Register relating to a medicine (other than an entry for goods in relation to which a fee specified in item 4 applies), if the evaluation documentation does not contain clinical or toxicological information	2 960
(d) under subsection 9D (1), (2) or (3) of the Act — in relation to an entry in the Register relating to a medicine (other than an entry for goods in relation to which a fee specified in item 4 applies), if the evaluation documentation contains clinical or toxicological information, and the total number of pages is:
(i) not over 50 pages	2 960
(ii) over 50 pages, but not over 250 pages	10 500
(iii) over 250 pages, but not over 500 pages	14 400
(iv) over 500 pages, but not over 1 000 pages	19 100
(v) over 1 000 pages, but not over 2 000 pages	28 700
(vi) over 2 000 pages, but not over 3 000 pages	38 300
(vii) over 3 000 pages	57 300
5A	Evaluation fee for subsection 24 (1) of the Act for a therapeutic device to which any of items 2 to 5 of Part 2 of Schedule 3 applies, and that involves the evaluation of:
(a) design or materials information or testing	4 290
(b) manufacture, quality control or sterile manufacture, or testing information	4 290
(c) biocompatability or pre‑clinical information	4 290
(d) software	4 290
(e) human clinical information	4 290
(f) control material for use with diagnostic goods for in vitro use	4 290
5B	Evaluation fee for subsection 24 (1) of the Act in respect of disinfectants or diagnostic goods for in vitro use	14 300
6	Evaluation fee for the purposes of subsection 24 (1) of the Act in respect of a therapeutic device to which any of items 1 to 4 of Part 1 of Schedule 3 applies involving the evaluation of:
(a) design or materials information or testing	25 100
(b) manufacture, quality control or sterile manufacture or testing information;	17 100
(c) biocompatability or pre‑clinical information;	17 100
(ca) software;	17 100
(d) human clinical information	28 700
6AA		Fee for processing of data in relation to goods, a step in the manufacture of which was carried out outside Australia (in addition to any other fee prescribed in this Schedule in relation to the application) to determine whether the manufacturing and quality control procedures used in the manufacture of the goods are acceptable: (a) for the purposes of subsection 9D (1), (2) or (3) of the Act; or (b) for the purposes of paragraph 25 (1) (g), 26 (1) (g), 31 (1) (e) or 31 (2) (d) of the Act	300
6AB		Fee for Department obtaining evidence from overseas regulatory authority of the manufacturing and quality control procedures used in the manufacture of goods, a step in the manufacture of which was carried out outside Australia (in addition to fee prescribed in item 6AA)	540
6ABA		Fee for desk audit of overseas compliance certification to identify third party certifications and review the overseas compliance certification by examining the underlying audit report and obtaining information from the overseas regulators	1 620
6AC		Fee for reinstatement of acceptance status of data relating to the manufacturing and quality control procedures used in the manufacture of goods, a step in the manufacture of which was carried out outside Australia (in addition to fee prescribed in items 6AA and 6ABA)	920
6AD		Fee for evaluation, under section 25 of the Act, in relation to a therapeutic device:
(a) establishing from overseas reports or data that the manufacture of the device is of an acceptable standard	17 100
(b) if a person makes simultaneous applications in relation to more than 1 device and the overseas reports or data in support of the application for each device have sufficient commonality that a simultaneous evaluation of the manufacture of each device may conveniently be made — performing the function mentioned in paragraph (a) in relation to each such additional device	4 290
6A		Fee for evaluation of data, under subsection 9D (1), (2) or (3) of the Act, about an entry in the Register relating to a therapeutic device to which any of items 2 to 5 of Part 2 of Schedule 3 applies	1 140
6B		Fee for evaluation of data, under subsection 9D (1), (2) or (3) of the Act, about an entry in the Register relating to disinfectants and diagnostic goods for in vitro use	2 870
6C		Fee for evaluating documents and other information, relating to the safety of a medicine, obtained under paragraph 31 (2) (f) of the Act (other than an evaluation to which item 6D applies)	6 240
6D		Fee for evaluating documents and other information, relating to the safety, quality and efficacy of a medicine, obtained under paragraphs 31 (2) (f) and (h) of the Act, if the total number of pages of the evaluation documentation is:
(a) not over 50 pages	8 190
(b) over 50 pages, but not over 250 pages	10 500
(c) over 250 pages, but not over 500 pages	14 400
(d) over 500 pages, but not over 1 000 pages	19 100
(e) over 1 000 pages, but not over 2 000 pages	28 700
(f) over 2 000 pages, but not over 3 000 pages	38 300
(g) over 3 000 pages	57 300
7	Evaluation fee for data submitted in support of a change to a therapeutic device to which any of items 1 to 4 of Part 1 of Schedule 3 applies, if the evaluation involves review of:
(a) design or materials information or testing	8 560
(b) manufacturing, quality control and sterile manufacture or testing information;	7 130
(c) biocompatability or pre‑clinical information;	7 130
(ca) software;	7 130
(d) human clinical information	28 700
(e) confirmatory review of clinical information	7 130
(f) confirmatory evaluation of overseas reports or data	7 130

[4] Schedule 9, Part 2, items 7A, 7B, 8, 9, 9AA, 9AB, 9AC, 9ACA, 9AD, 9B and 9C

substitute

7A	Fee for evaluation under paragraph 16GA (1) (a):
(a) if the evaluation documentation does not contain clinical or toxicological information	8 190
(b) if the evaluation documentation contains clinical or toxicological information, and the total number of pages is:
(i) not over 50 pages	8 190
(ii) over 50 pages, but not over 250 pages	10 500
(iii) over 250 pages, but not over 500 pages	14 400
(iv) over 500 pages, but not over 1 000 pages	19 100
(v) over 1 000 pages, but not over 2 000 pages	28 700
(vi) over 2 000 pages, but not over 3 000 pages	38 300
(vii) over 3 000 pages	57 300
7B	Fee for evaluation, under paragraph 16GA (1) (b), in relation to 1 or more new excipients for use in particular therapeutic goods: (a) if the evaluation documentation does not contain clinical or toxicological information (b) if the evaluation documentation contains clinical or toxicological information, and the total number of pages is:	8 190
(i) not over 50 pages	8 190
(ii) over 50 pages, but not over 250 pages	10 500
(iii) over 250 pages, but not over 500 pages	14 400
(iv) over 500 pages, but not over 1 000 pages	19 100
(v) over 1 000 pages, but not over 2 000 pages	28 700
(vi) over 2 000 pages, but not over 3 000 pages	38 300
(vii) over 3 000 pages	57 300
8	Application fee for the purposes of paragraph 37 (1) (g) of the Act	790
9	(a) Fee for paragraphs 38 (1) (c), 41 (1) (f) and 58 (3) (b) of the Act for inspection within Australia (except for therapeutic goods mentioned in items 9AA, 9AB, 9AC and 9ACA), per hour, per inspector, for:	520
(i) the manufacture of therapeutic goods; or
(ii) a step in the manufacture of therapeutic goods; or
(iii) the manufacture of ingredients or components for use in the manufacture of therapeutic goods; or
(iv) the manufacture of herbal or homoeopathic preparations; or
(v) the manufacture of diagnostic goods for in vitro use
(b) Fee for paragraphs 38 (1) (c), 41 (1) (f) and 58 (3) (b) of the Act for inspection outside Australia, per hour, per inspector, for inspection of a kind mentioned in paragraph (a)	1 060
9AA	Fee for inspection (including an inspection for paragraph 58 (3) (b) of the Act) of manufacturing premises or operations for the preparation of haematopoietic progenitor cells under licence, for each inspector engaged per hour, or part of an hour	520
9AB	Fee for inspection (including an inspection for paragraph 58 (3) (b) of the Act) of manufacturing premises or operations for the preparation of human blood and blood components (other than haematopoietic progenitor cells) under licence, at the primary site covered by the licence, for each inspector engaged per hour, or part of an hour	710
9AC	Fee for inspection (including an inspection for paragraph 58 (3) (b) of the Act) of manufacturing premises or operations for the preparation of human blood and blood components (other than haematopoietic progenitor cells) under licence, at a site covered by the licence other than the primary site, for each inspector engaged per hour, or part of an hour	520
9ACA	Fee for inspection (including an inspection for paragraph 58 (3) (b) of the Act) of manufacturing premises or operations for the preparation of human tissues under licence, for each inspector engaged per hour, or part of an hour	520
9AD	Fee for paragraph 25 (1) (g) or (h), or 26 (1) (g) or (h) of the Act (and, in relation to associated inspections, for paragraphs 38 (1) (c), 41 (1) (f) and 58 (3) (b) of the Act), in respect of the evaluation of the manufacture of human blood and blood components prepared under licence by reference to data contained in files known as technical master files or plasma master files, where the total number of pages of each file referred to is:
(a) not over 10 pages	1 030
(b) over 10 pages, but not over 50 pages	8 870
(c) over 50 pages, but not over 100 pages	19 700
(d) over 100 pages, but not over 1 000 pages	26 500
(e) over 1 000 pages, but not over 3 000 pages	41 400
(f) over 3 000 pages, but not over 4 000 pages	55 000
(g) over 4 000 pages	67 000
9B	Evaluation fee for assessing, for paragraph 26 (1) (d) of the Act, whether a therapeutic device is safe for the purposes for which it is to be used	14 300
9C	Fee for evaluating documents and other information, relating to the safety of a listed therapeutic device, obtained under paragraph 31 (2) (f) of the Act	14 300

[5] Schedule 9, Part 2, item 10

substitute

Fee for an application for certification under paragraph 58 (3) (a) of the Act

130 multiplied by the number of certifications sought in the application

[6] Schedule 9, Part 2, items 14 and 14A

substitute

14	Fee for notification of intention to sponsor a clinical trial using a specified medicine	270
14A	Fee for notification of intention to sponsor a clinical trial using a specified therapeutic device, if the sponsor of the device notifies the Secretary, in accordance with item 3 of Schedule 5A, of 1 or more bodies or organisations conducting the trial for the sponsor, including the sponsor, if the sponsor is conducting the trial (whether or not the sponsor has previously notified the Secretary of 1 or more bodies or organisations conducting the trial)	270

[7] Schedule 9, Part 2, items 17, 17A and 18

substitute

17	Fee for an application, under regulation 5F, for approval of an advertisement intended to be published in specified media (other than broadcast media):
(a) if the time needed to process the application is an hour or less — for an advertisement:
(i) of not more than 100 words	190
(ii) of more than 100 words	230
(iii) of more than 300 words (including an advertorial)	370
(iv) that is intended for publication in the classified advertisement columns of a newspaper or other publication	90
(b) if the time needed to process the application is more than an hour	The fee applicable under paragraph (a) plus $170 for each additional hour or part of an hour
(c) if the application is for approval of a minor change to an approved advertisement (other than a change to information of the kind mentioned in paragraph 5C (2) (b), (e) or (f) of these Regulations) and the application is made more than 3 months after the advertisement was approved	90
(d) if the application is for approval of an advertisement that is identical to an approved advertisement the approval number of which has expired under subregulation 5J (3)	50% of the fee applicable under paragraph (a) and, if applicable, paragraph (b)
(e) if the application is for approval of a variation of an approved advertisement the approval number of which has not expired under subregulation 5J (3)	50% of the fee applicable under paragraph (a) and, if applicable, paragraph (b)
17A	Fee for an application, under regulation 5F, for approval of an advertisement intended to be broadcast in broadcast media:
(a) if the time needed to process the application is an hour or less — for an advertisement that is:
(i) a television or cinema advertisement of not more than 150 seconds, including up to 3 variations of the advertising concept for the same product	940
(ii) a television advertisement for a retail outlet that is intended to be broadcast on 1 regional station only in that station’s regional area	490
(iii) a television advertorial of more than 150 seconds:
(A) for the first minute of each script	710
(B) for each additional minute or part of a minute of each script	200
(iv) a radio advertisement, including up to 6 variations of the advertising concept for the same product	340
(v) a radio advertisement that is intended to be broadcast in a regional area only, including up to 6 variations of the advertising concept for the same product	240
(vi) a still cinema media advertisement (including outdoor media):
(A) of not more than 100 words	190
(B) of not more than 300 words	230
(C) of more than 300 words	370
(b) if the time needed to process the application is more than an hour	The fee applicable under paragraph (a) plus $170 for each additional hour or part of an hour
(c) if the application is for approval of a minor change to an approved advertisement (other than a change to information of the kind mentioned in paragraph 5C (2) (b), (e) or (f) of these Regulations) and the application is made more than 3 months after the advertisement was approved	50% of the fee applicable under paragraph (a) and, if applicable, paragraph (b)
(d) if the application is for approval of an advertisement that is identical to an approved advertisement the approval number of which has expired under subregulation 5J (3)	50% of the fee applicable under paragraph (a) and, if applicable, paragraph (b)
(e) if the application is for approval of a variation of an approved advertisement the approval number of which has not expired under subregulation 5J (3)	50% of the fee applicable under paragraph (a) and, if applicable, paragraph (b)
18	Fee for testing a sample of, and providing advice in relation to, a prescription medicine on request by the Pharmaceutical Benefits Program of the Department before listing the medicine in the Pharmaceutical Benefits Listing Program of the Department	1 730

[8] Further amendments

*Provision*	*omit*	*insert*
Paragraph 45 (4A) (a)	$8 210	$8 560
Paragraphs 45 (4A) (b), (c) and (ca)	$6 840	$7 130
Paragraph 45 (4A) (d)	$27 500	$28 700
Paragraphs 45 (4A) (e) and (f)	$6 840	$7 130
Paragraph 45 (9) (a), (b), (c), (ca), (d) and (e)	$4 110	$4 290
Paragraphs 45 (11) (a), (b), (c), (ca), (d) and (e)	$1 510	$1 570
Subregulation 45A (1)	$73 600	$76 800

Note

All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See